Search Results Within Category "Blood Disorders"
A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients
Study of the safety of unlicensed cord blood units for stem cell transplant of children and adults.
For the treatment arm of this study you will no receive the total body radiation (TBI) as typically given before transplant. In this study you will have various research procedures such as a Blast sample at the screening part of the study, and MRD testing of your bone marrow and blood at screening and through the course of the study. Participation in the treatment arm (Non-TBI) of the study will last up to 5 years.
You are receiving unlicensed CB products from other CB banks
ATHN 10: Rare Coagulation Disorders Project
This is a multi-center project in which the American Thrombosis & Hemostasis Network (ATHN) will offer free genotyping to individuals with Rare Coagulation Disorders (RCD).
One tube of blood will be collected during a routine clinic visit.
Must currently receive or have received care at and ATHN affiliated HTC
Subject must have opted into the ATHNdataset
A Phase 3, single-arm, open-label, multicenter study of thesafety and efficacy of dirloctocogene samoparvovec(SPK-8011, adeno-associated viral vector with B-domaindeleted human factor VIII gene) in adults with severe ormoderately severe hemophilia A (KEYSTONESM 1)
This is a Phase 3 study of single-dose SPK-8011 AAV gene therapy in combination with immunomodulation. Patients will receive a one-time dose of SPK 8011, three weeks of methylprednisolone & then will be followed for safety & efficacy per study schedule.
1) Screening period of < 8wks.-1 visit2) Lead-in for >24 wks.-1 visit3) Pre-dose day -24-1 visit4) Dosing-Day 1 & Day 2-2 visits5) Primary study (15 mos.)-37 visits6) Long term follow-up approx. 9 yrs.-20 visitsSome visits may be done via home health when a physical isn't required.
$75.00 travel reimbursement per visit
>150 documented exposure days to a FVIII protein product
No evidence of cirrhosis or advanced liver disease
Negative test for inhibitor against FVIII during screening
No documented FVIII inhibitor in 5 yrs. prior to screening
Currently undergoing antiviral therapy
Have an inherited bleeding or acquired disorder other than hemophilia A
Prior treatment with a vector or gene transfer agent
Major surgical procedure planned in a 15 month period following SPK 8011 infusion
Understanding the Relationship Between Discrimination and Sickle Cell Pain
This is a survey and interview study recruiting patients with sickle cell disease (SCD). Participants will answer questionnaires and complete a remote interview about health care experiences, pain, and discrimination. Natural language processing of interview transcripts will be used to quantify linguistic features indicative of subjective associations between individual experiences of racial discrimination and sickle cell pain.
Participants will be asked to fill out questionnaires and answer questions during an interview.
$50
18 years or older
Does not have a confirmed diagnosis of Sickle Cell Disease
Unable or unwilling to participate in the interview or to be recorded
Not Fluent in the English langauge
A Global, Open-Label, Adaptive Design Study to Investigate the Efficacy and Safety of SerpinPC With Severe Hemophilia A or Moderately Severe to Severe Hemophilia B
This is an open-label drug study of SerpinPC (a subcutaneously administered drug) for patients with severe hemophilia A or moderately severe to severe Hemophilia B. The study consists of 3 parts after an observation phase of 12-24 weeks: 24 week justification phase, 24 week confirmatory phase & 24 week extension phase.
This is a subcutaneous drug treatment clinical trial with an observation period of up to 24 weeks, pre-dosing/dosing period of 8 visits on site or phone calls & an extension period of 6 visits.
$75.00 travel reimbursement per visit
Subjects include prophylactic dosing or on-demand dosing for factor replacement
Adequate laboratory functions
Previous deep vein thrombosis, pulmonary embolism, MI or stroke.
Uncontrolled hypertension, active cancer (except basal cell)
Weight > 150kg (330 lbs.) or BMI > 40kg/m2
Open-label safety study in adults and adolescents with haemophilia A with and without FVIII inhibitors switching directly from emicizumab prophylaxis to NNC0365-3769 (Mim8) prophylaxis
A research study looking at how safe it is to switch from emicizumab (Hemlibra) to Mim8 in people with haemophilia A.
The study will last for about 6-12 months. Subjects will have between 6 and 27 Mim8 injections depending on dosing frequency. There will be 9 clinic visits. Blood will be drawn at all 9 of the visits.
$75 per visit to cover travel expenses
Treated with emicizumab QW, Q2W, or Q4W according to the label for at least 8 weeks prior to screening.
Age 12 years or above at the time of signing the informed consent.
Patients for whom the decision to discontinue emicizumab treatment has been made.
Willingness and ability to comply with scheduled visits and study procedures, including the completion of an electronic diary and patient-reported outcomes (PRO) questionnaires.
Previous or current thromboembolic disease or events or risk of thromboembolic disease, as evaluated by investigator or risk of thromboembolic disease, as evaluated by investigator.
Receipt of FVIII gene therapy at any time.
Ongoing or planned immune tolerance induction therapy.
Minor or major surgery planned to take place after screening and during the 26-week treatment period.
External performance evaluation of INNOVANCE D-Dimer 2.0 on CS-5100
This is a multi-site prospective laboratory analysis of blood specimens utilizing the investigational Innovance 2.0 D-Dimer assay compared to the FDA-approved Innovance 1.0 D-Dimer assay on the FDA-approved CS-5100 instrument. Subjects will be required to provide up to 2 tablespoons of blood (30 ml) collected once (1) in a single visit from up to two (2) attempts to obtain the sample. Samples will be collected by venipuncture, or from an existing intravenous (IV) or arterial line, which are the standard methods of drawing blood in the hospital setting.
If you choose to participate in the study, you will have no more than 2 tablespoons of blood (30 ml) collected once (1) in a single visit from up to two (2) attempts to obtain the sample. Samples will be collected by venipuncture, or from an existing intravenous (IV) or arterial line, which are the standard methods of drawing blood in the hospital setting. The visit should last no more than 60 minutes and will be scheduled in advance with the study team. This visit will include signing a consent form to participate in the study, allowing the study team to draw your blood, and providing a small amount of information about yourself. We are looking for volunteers 10 years and older with confirmed clots in the legs or lungs, or diseases and conditions with increased coagulation activation such as thromboembolic disease, acute aortic dissection, myocardial infarction, malignant diseases, obstetrical complications, third trimester of pregnancy, surgery or polytrauma, sepsis or severe infection. We are looking for healthy volunteers 18 years and older as well.
$75
Patient with known clot or condition above
Healthy adult (>18) volunteer
Willing to donate a small amount of blood
If healthy volunteer, currently pregnant or hospitalization within the past month
Unable to find transport to Hershey Medical Center for a 1 hour visit on 1 day
Strenuous exercise in the 60 minutes prior to blood draw
External design verification study on CN-6000 system.
The purpose of this prospective, multi-site study is to conduct a clinical evaluation of the investigational CN-6000 device using venous plasma specimens from adult participants in different care settings with various disease processes. This is a fully automated blood coagulation analyzer intended for in-vitro diagnostic use to analyze clotting, chromogenic and immuno-chemical methods in 3.2% Na citrated plasma in a clinical laboratory. No more than 2 venous blood draws will be attempted to obtain up to 4 whole blood specimens per subject, totaling no more than 30 mL. Samples may also be tested on the CS-5100 predicate comparator device.
This study will require 1 visit to Hershey Medical Center on a single day for up to two blood draws, no more than 2 tablespoons of blood (30 ml) total. The visit should last no more than 60 minutes and will be scheduled in advance with the study team. This visit will include signing a consent form to participate in the study, allowing the study team to draw your blood, and providing a small amount of information about yourself. We are looking for volunteers with coagulation disorders and healthy volunteers.
$75
Patient with known or tested for clotting disorders
Patients with severe liver disease
Healthy people without clotting disease or recent hospital stay
Willing to undergo blood draw
Less than 18 years of age
Unable to find transport to Hershey Medical Center for a 1 hour visit on 1 day